Monthly Archives: January 2013

Trends in R&D: The Widening Gap between Success and Failure

By Clark Herman | Published: January 31, 2013
The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years. The study finds that out-of-pocket costs to bring a new medicine to market have increased over this period by 600%, success rates from proof of concept to registration have decreased at least twofold since the [...]
Posted in Emerging Markets, Europe, R&D, Strategy, Technology | Tagged | 1 Comment

Five Compliance Questions to Ask Yourself, from the DOJ

By Ben Comer | Published: January 31, 2013
At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves [...]
Posted in Corporate Responsibility, Legal, Regulatory, Safety, Strategy, compliance, leadership | Tagged , , | Leave a comment

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

By Jill Wechsler | Published: January 30, 2013
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Posted in Advertising, Agency Insight, E-Media, FDA, Legal, Marketing, Regulatory, leadership, social media | Tagged , , , , , , , | 1 Comment

Is There a Global Policy Gap on Cancer?

By William Looney | Published: January 30, 2013
Eli Lilly thinks so, with a new “back to school” pathway on stakeholder engagement Monday, February 4, is World Cancer Day.  Eli Lilly & Co., one of big Pharma’s biggest, has decided to give the moment its due with the launch of a new policy advocacy initiative to ensure that patients actually benefit from the [...]
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The Strange Twists and Turns of 'Pay for Delay'

By Clark Herman | Published: January 30, 2013
In the arcane world of patent litigation, the term ‘pay for delay’ can be misleading, and as the Washington debate to restrict these deals unfolds, it is becoming apparent that a  ban on such settlements may serve to delay generics even further.  Is the fresh grass of reform really always greener than the well-seeded status [...]
Posted in IP, Legal, Market Access, Regulatory, Strategy | Tagged , | Leave a comment